ENOXAPARIN 6000 IU

ENOXAPARIN is indicated in adults for:

• Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery.
• Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism.
• Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery.
• Prevention of thrombus formation in extra corporeal circulation during haemodialysis.
• Acute coronary syndrome

- Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.

- Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

Pharmacotherapeutic group: Antithrombotic agent, heparin group

ENOXAPARIN works in two ways.

• Stopping existing blood clots from getting any bigger. This helps your body to break them down and stops them from causing you harm.
• Stopping blood clots from forming in your blood.

Please refer to the instructions on the prescription established by your medical doctor.

ENOXAPARIN is usually given by injection underneath the skin (subcutaneous).

Do not inject ENOXAPARIN into a muscle.

1. Treating blood clots that are in your blood

• The usual dose is 150 IU (1.5 mg) for every kilogram of your weight each day or 100 IU (1 mg) for every kilogram of your weight twice a day.
• Your doctor will decide how long you should receive ENOXAPARIN.

2. Stopping blood clots forming in your blood in the following situations:

• Operation or periods of limited mobility due to an illness
        o The dose will depend on how likely you are to develop a clot. You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of ENOXAPARIN  each day.
         o If you are going to have an operation your first injection will be usually given 2 hours or 12 hours before your operation.
        o If you have restricted mobility due to illness, you will normally be given 4,000 IU (40 mg) of ENOXAPARIN  each day.
        o Your doctor will decide how long you should receive ENOXAPARIN .
• After you have had a heart attack

ENOXAPARIN can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non STEMI (NSTEMI). The amount of ENOXAPARIN given to you will depend on your age and the kind of heart attack you have had. NSTEMI type of heart attack:

      o The usual dose is 100 IU (1 mg) for every kilogram of weight every 12 hours.
      o Your doctor will normally ask you to take aspirin (acetylsalicylic acid) as well.
      o Your doctor will decide how long you should receive ENOXAPARIN.

STEMI type of heart attack if you are under 75 years old:
      o An initial dose of 3,000 IU (30 mg) of ENOXAPARIN  will be given as injection into your vein.
      o At the same time you will also be given ENOXAPARIN  as an injection underneath your skin (subcutaneous injection). The usual dose is 100 IU (1 mg) for every kilogram of your weight, every 12 hours.
     o Your doctor will normally ask you to take aspirin (acetylsalicylic acid) as well.
     o Your doctor will decide how long you should receive ENOXAPARIN .

STEMI type of heart attack if you are 75 years old or older:
     o The usual dose is 75 IU (0.75 mg) for every kilogram of your weight, every 12 hours
     o The maximum amount of ENOXAPARIN given for the first two injections is 7,500 IU (75mg).
     o Your doctor will decide how long you should receive ENOXAPARIN .

For patients that have an operation called percutaneous coronary intervention (PCI):
Depending on when you were last given ENOXAPARIN , your doctor may decide to give an additional dose of ENOXAPARIN  before a PCI operation. This is by injection into your vein.

3. Stopping blood clots from forming in the tubes of your dialysis machine
    o The usual dose is 100 IU (1 mg) for every kilogram of your weight
    o is added to the tube leaving the body (arterial line) at the start of the dialysis session. This amount is usually enough for a 4-hour session. However, your doctor may give you a further dose of 50 IU to 100 IU (0.5 to 1 mg) for every kilogram of your weight, if necessary.

Changing of anticoagulant treatment

• Changing from ENOXAPARIN  (and associated names) to blood thinners called vitamin-K antagonists (e.g. warfarin).Your doctor will request you perform blood tests called INR and tell you when to stop ENOXAPARIN  accordingly.
• Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to ENOXAPARIN .Stop taking the vitamin-K antagonist. Your doctor will request you perform blood tests called INR and tell you when to start ENOXAPARIN  accordingly.
• Changing from ENOXAPARIN  to treatment with direct oral anticoagulant. Stop taking ENOXAPARIN . Start taking the direct oral anticoagulant 0-2 hours before the time you would have had the next injection, then continue as normal.
• Changing from treatment with direct oral anticoagulant to ENOXAPARIN. Stop taking direct oral anticoagulant. Do not start treatment with ENOXAPARIN until 12 hours after the final dose of direct oral anticoagulant.

Instructions for use of the syringe: Please refer to the Patient Information Leaflet provided above for detailed information.